Advantages of the lipoprotein-associated phospholipase A2 activity assay.

Objectives: Lipoprotein-associated phospholipase A2 (Lp-PLA2) is increased in circulation in patients at higher risk of coronary heart disease (CHD) events and stroke. Therefore, measurement of Lp-PLA2 can be used as an adjunct to traditional cardiovascular risk factors for identifying individuals at higher risk of cardiovascular events. Recently, a reagent for measuring Lp-PLA2 activity (diaDexus, San Francisco, CA) received FDA approval.

Assessment of clinical performance without adequate analytical validation: A prescription for confusion.

Objectives: Lp-PLA2 is a biomarker with promise for predicting cardiac risk. The lack of reproducible results has limited its use. In evaluating a new reagent kit, we investigated conditions for optimal reproducibility.